Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS

Key Who May Qualify: - Definite ALS or Probable ALS using the El Escorial criteria. - Symptom onset of ≤18 months at screening. - Slow vital capacity (SVC) greater or equal to 60% predicted. - Treatment Research Initiative to Cure ALS (TRICALS) Risk Profile Calculator score, based on the European Network for the Cure of ALS (ENCALS) survival prediction model, in the range of -6 to -2, inclusive, at screening. - Able to swallow a capsule. Key Who Should NOT Join This Trial: - Presence of tracheostomy or permanent assisted ventilation. - Clinically significant heart disease, clinically significant history of arrhythmia, symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia, or presence of left bundle branch block. - Presence of unstable psychiatric disease, cognitive impairment, dementia or substance abuse that would impair ability of the participant to provide willing to sign a consent form and participate in the study. - Clinically significant and/or unstable medical condition (other than ALS) that may either pose a clinically meaningful risk to the participant and/or to study completion. - Use of medications that prolong QT interval. - Previous treatment with pridopidine, gene therapy, or antisense oligonucleotides. - Confirmed mutation in the SOD1, FUS or C9orf72 gene. - Pregnancy. Always talk to your doctor about whether this trial is right for you.